NEUROCARE PRO ACCELERATED WOUND RECOVERY HOME CARE SYSTEM.
Received Dec 23, 2025 · Event occurred Dec 9, 2025
Report MW5181099 · MDR key 23881419
Device
Generic name
Lamp, Infrared, Therapeutic Heating
Manufacturer
Neurocare Pro LlcProduct problems
- Overheating of Device
- Device Markings/Labelling Problem
Patient
78 YR · Male
- Skin Burning Sensation
- Skin Burning Sensation
Narrative
Description of Event or Problem
I BOUGHT A MEDICAL DEVICE FOR LABELED ACCELERATED WOUND RECOVER HOME CARE SYSTEM. I USED IT AS DESCRIBED IN THEIR VIDEO AND AS THEY DIRECT, AND WITHIN A FEW MINUTES THE PAD STARTED HEATING UP. REALLY QUICKLY, THE PLASTIC BEGAN TO TURN RED AND THE HEAT WAS RADIATING OFF THE PLASTIC. I HAD TO TEAR THE THING OFF MY SKIN BECAUSE IT STARTED TO STICK. I'M 78 YEARS OLD AND THIS IS SUPPOSED TO HELP WITH WOUND CARE, BUT ALL THIS DID WAS MAKE MY WOUND WORSE. THIS ISN'T A MEDICAL DEVICE, THIS A NOTHING LIKE A MEDICAL DEVICE. SOMEONE NEEDS TO INVESTIGATE THIS PLEASE. WHEN I WENT TO GET THE INFORMATION OFF IN THE DEVICE TO CONTACT THE MANUFACTURER THERE IS NO INFORMATION TO CONTACT THEM JUST A WEBSITE. NO PHONE NUMBER, NO ADDRESS, NO BAR CODES THAT CAN BE SCANNED, NO LABELS, NO WARNINGS. NOTHING. HOW DO YOU GUYS AT THE FDA REGISTER AND APPROVE THESE GUYS? THERE IS NO UDI ON THE DEVICE. THERE IS NOTHING ON THIS DEVICE THAT TELLS. YOU ANYTHING ABOUT THE DEVICE OR MANUFACTURER. THIS IS (PROFANITY) NOT A REAL FDA MADE DEVICE IT'S A CHINESE KNOCK OFF WITH NO STANDARD FDA MARKINGS.